24^th Annual EuroMeeting, Drug Information Association – Europe, Copenhagen, March 26-28, 2012
Adverse Event Reporting from Market Research/Patient Support Programmes - How can compliance be achieved by all stakeholders? (Speaker: Melanie Weber)

The European Centre of Regulatory Affairs Freiburg (EUCRAF) Masters Course in collaboration with the University of Strasbourg, Seminar 6, Freiburg, May 31 – June 01 (02), 2012
Pharmacovigilance – Post-authorisation surveillance standards to meet regulatory requirements for product safety (Course Leader and Lecturer: Dr. Monika Pietrek)

Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice (EFGCP) Workshop – Adapting to the new EU pharmacovigilance legislation, London, June 12-13, 2012
(Programme Committee Member: Dr. Monika Pietrek)

48^th Annual Meeting, Drug Information Association: Collaborate to Innovate, Philadelphia, Pennsylvania, June 24-28, 2012

6^th Annual Clinical Forum, Drug Information Association, The Hague, October 08-10, 2012
Drug Safety and Risk Management (Co-Theme Leader: Dr. Monika Pietrek)

2012
What currently matters for Biopharmaceuticals in Europe (Speaker: Dr. Monika Pietrek)
2^nd Annual EUCRAF Workshop, Freiburg, February 02-03, 2012

2011
Good Clinical Practice (GCP) - Audits and Inspections (Speaker
Dr. Monika Pietrek)
European Organisation for Research and Treatment of Cancer (EORTC) course “Organisation and Implementation of Cancer Clinical Trials”, Leuven, December 02, 2011

Update on European Regulatory Trends (Speaker Dr. Monika Pietrek)
Pharmaceuticals and Medical Device Agency (PMDA) Japan & Tokyo University Medical Institute, October 31, 2011

Cross Functional Working for better Results (Program Committee Member: Dr. Monika Pietrek)
Drug Safety and Risk Management (Theme Co-Chairs: Dr. Monika Pietrek and Dr. Liliana Hansen)
The Clinical Trial Approval Process (Session Chair: Dr. Monika Pietrek)
How to manage Risks in Clinical Trials effectively? (Session Chair:
Dr. Monika Pietrek)
Risk Management in Clinical Trials – Approach and implication (Speaker: Dr. Monika Pietrek)
5^th Annual Clinical Forum, Basel, October 10-12, 2011

NIS - Which Design for which Research Question? (Speaker: Dr. Monika Pietrek)
Quality Management for Non-interventional Studies (Speaker:
Dr. Monika Pietrek)
53. Klinischer Studientag: „Non-interventional Studies“, CenTrial, Stuttgart, September 22, 2011

Pharmacovigilance- Post-authorisation surveillance standards to meet regulatory requirements for product safety (Course Leader and Lecturer: Dr. Monika Pietrek)
EUCRAF Seminar 6, Freiburg, May 19-20, 2011

QPPV Governance/Oversight: Local vs. EU QPPV, Affiliate oversight, Patient Support Programmes (Speaker: Dr. Monika Pietrek)
5^th European Forum for Qualified Person for Pharmacovigilance (QPPV), London, May 10-12, 2011

How will the pharmaceutical package impact day-to-day pharmacovigilance operations? (Session Chair: Dr. Monika Pietrek)
23^rd Annual EuroMeeting, Geneva, March 28-30, 2011

Overview of the existing Clinical Trial Directive and an update on the future plans in the European Union (Speaker: Dr. Monika Pietrek)
2^nd Annual Meeting of the Japanese Society of Clinical Trials and Research, Osaka, February 04-05, 2011

Pietrek M. & Bendall C. Pharmacovigilance Terminology and the new EU Pharmacovigilance Legislation. Global Forum. December 2011; 3 (6): 10-17.

Pietrek M. How to Train your Staff for Pharmacovigilance Inspection Readiness in the EU. Quasar. July 2011; 21-27.

Pietrek M.M. Background on the Assessment of a Drug-event Relationship. Global Forum. 2010; 2 (6): 64-66.